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BRAF Inhibitor

Immunotherapy + Targeted Therapy for Melanoma

Phase 3
Waitlist Available
Led By Michael B Atkins
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of dabrafenib or dabrafenib + trametinib or nivolumab or nivolumab + ipilimumab therapy in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing two different treatments for melanoma that cannot be removed by surgery. The first treatment is immunotherapy with monoclonal antibodies, followed by targeted therapy with dabrafenib and trametinib. The second treatment is targeted therapy with dabrafenib and trametinib, followed by immunotherapy with monoclonal antibodies. It is not yet known which treatment is more effective.

Who is the study for?
Adults with stage III-IV melanoma that can't be surgically removed and have the BRAFV600 mutation. They should not have HIV, other cancers within the last 5 years (except certain skin cancers), serious medical conditions, or be pregnant/breastfeeding. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing two treatment sequences for advanced melanoma: starting with ipilimumab and nivolumab (immunotherapies) followed by dabrafenib and trametinib (targeting BRAFV600 gene), versus starting with dabrafenib and trametinib followed by immunotherapies, to see which is more effective.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, infusion-related reactions from antibodies, heart issues due to targeted therapies, liver problems, skin rash, fever, fatigue, eye problems like blurred vision or dry eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 18 years old or older.
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My cancer is at an advanced stage and cannot be removed with surgery.
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My cancer has a BRAF V600 mutation confirmed by an approved test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My melanoma cannot be removed by surgery and has been confirmed by tests.
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My melanoma has the BRAF V600 mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) rate
Secondary outcome measures
Progression-free survival (PFS)
Response rate
Toxicity rate for categorized AEs
+2 more
Other outcome measures
Change in patient-reported symptoms
Genetic characteristics
Immune-related adverse events (irAE) status
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D (immunotherapy)Experimental Treatment7 Interventions
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Group II: Arm C (BRAF inhibitor therapy)Experimental Treatment7 Interventions
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Group III: Arm B (BRAF inhibitor therapy)Experimental Treatment7 Interventions
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Group IV: Arm A (immunotherapy)Experimental Treatment7 Interventions
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multigated Acquisition Scan
2015
Completed Phase 2
~50
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Dabrafenib Mesylate
2014
Completed Phase 2
~10
Echocardiography
2013
Completed Phase 4
~11670
Ipilimumab
2014
Completed Phase 3
~2620
Trametinib Dimethyl Sulfoxide
2014
Completed Phase 2
~10
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,708 Previous Clinical Trials
40,932,429 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Michael B AtkinsPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Dabrafenib Mesylate (BRAF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02224781 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Quality-of-Life Assessment impact patients in the short and long run?

"There is some evidence from previous clinical trials to suggest that Quality-of-Life Assessment is safe, so it receives a score of 3."

Answered by AI

How does Quality-of-Life Assessment help researchers get a better understanding of patients?

"Quality-of-Life Assessment can improve the prognosis for patients struggling with unresectable melanoma, squamous cell carcinoma, and those at high risk of cancer recurrence."

Answered by AI

Are there other ongoing clinical trials that focus on Quality-of-Life Assessment?

"The first Quality-of-Life Assessment study was done in 2009 at Texas Children's Hospital. So far, there have been 646 completed clinical trials and 891 live clinical trials. Many of these live trials are based in Bardstown, Kentucky."

Answered by AI

Is recruitment for this clinical trial currently ongoing?

"Unfortunately, this trial is no longer taking patients. The listing was created on July 13th, 2015 and edited for the last time on October 4th, 2022. If you are interested in other studies, 855 trials for recurrent melanoma and 891 for Quality-of-Life Assessment are still admitting patients."

Answered by AI

Could you please tell us how many different facilities are participating in this research project?

"There are presently 100 locations where this clinical trial is running. Some notable locations are Bardstown, Post Falls and Las Vegas. To cut down on travel, make sure to enroll at a location near you."

Answered by AI

What is the total number of individuals who have signed up for this research project?

"This trial is no longer admitting patients. The listing for this trial was created on July 13th, 2015 and edited for the last time on October 4th, 2022. However, there are 855 other trials for recurrent melanoma and 891 for Quality-of-Life Assessment currently admitting patients."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Alta Bates Summit Medical Center-Herrick Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~19 spots leftby Dec 2024